master formula record dopamine hydrochloride injection

NAME OF PRODUCT : DOPAMINE HYDROCHLORIDE INJECTION 5 ML AMPOULE

COMPOSITION : Each ml Contains:
Dopamine Hydrochloride 40 mg/ml
Water for injection I.P. q.s.

BATCH SIZE : 100 Litres

SELF LIFE : 2.0 Years

PACKAGING : 5 ml Amber ampoule

MANUFACTURING FORMULA

Sr. No.	Raw Material	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Dopamine Hydrochloride	40mg	–	40mg	4.00 kg
02.	Sodium Chloride	4.5mg	–	4.5mg	450gm
03.	Sodium Metabisulphite	1.92mg	–	1.92mg	192gm
04.	Water for injection	Q.S.	–	Q.S.	Q.S.

CALCULATION : Dopamine Hydrochloride U.S.P.40 mg/ml

–For each ml

— 100

— _____________ x 40 mg x 100 Litres

— (Assay – Water)

–( Assay according to Quality Control Report )

EQUIPMENT USED :

PROCESS STEGE EQUIPMENT AND VESSELS

1) DISPENSING

(a) Weighing Machine
(b) S.S.Scoop
(c) S.S.Containers/Polybags

2) BULK MANUFACTURING

(a) 50 Litre S.S.Tank with lid and stirrer.
(b) 100 Litre S.S.Tank with lid and stirrer.
(c) 142 mm/293 mm filter assembly.

3) FILTERATION

(a) Bubble point Apparatus
(b) Filtration Assembly – 142 mm /293 mm
(c) 20 litres/50 litres receivingVessels / filling tank
(d) Autoclave.

4) FILLING & SEALING

(a) Automatic Ampoule filling and sealing machine
(b) S.S.Container / Tray

5) AMPOULE WASHING

(a) Ampoule washing machine
(b) S.S.Boxes / Tray
(c) Dry Heat Sterilization (D.H.S.)

6) LEAK TESTING

(a) Vaccum Pump
(b) Autoclave

7) OPTICAL TESTING

(a) Optical testing tables.

8) BATCH PRINTING

(a) Batch printing machine

9) LABELLING & PACKING

(a) Labelling machine
(b)Taping machine
(c) Strepping machine

GENERAL DISPENSING PROCEDURES :

THE MAIN STEPS IN DISPENSING AREA :

Transaction with Raw Material Store :

Depending upon the production programme and availability of raw materials,bulk requisitions duly

authorized by Production Manager / Mfg . Chemist , must be given to store , 2 hour’s in advance .

While receiving the materials should be checked by concerned Supervisor for the following :-

a) Label
b) A.R. Number from Q.C.
c) Quantity
d) Checking of weight in the weighing room
e) Physical damage if any.

DISPENSING

On receiving the raw materials requisition, the materials are dispensed in the following manner.

DEPACKING

Materials contained in polythene bags are first depacked into s.s.container and duly labeled . Materials

received in fibre drums and carbous need not be depacked, only external cleaning with a clean dry cloth is sufficient.

WEIGHING

The materials are dispensed as per the requisition duly authorized by Production Manager / Mfg.Chemist received from the production department. The materials are weighed on electronic balance. All the materials dispensed are weighed by on Supervisor and counter checked by another Supervisor.

BULK MANUFACTURING :

Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M. Water.
In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
Collect 80 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.Then set pH by Hcl dilute stir to dissolve.
Then add sodium Metabisulphite , sodium chloride then add Dopamine Hydrochloride slowly and stir till clear solution with continuous sterring.
Finaly check and adjust the pH between 2.5 to 5.0.
Make-up the volume upto 100 litres.

PREPARATION OF FILTER ASSEMBLY :

To be done under controlled environment , use 142 mm / 293 mm filter assembly . Before using ,

dismantle all parts of the assembly like plates, lower plate, upper plate, clamps, nozzles , distributors,

gasket , distributing net etc . wash them with teepol , raw water and then washed with hot distilled water .cool them for better handling.

Mounting is done as follows:
1) Put lower plate on legs.
2) Put distributing net on lower plate on that the sieve is kept.
3) Put membrane filter on sieve, do not touch the paper on any surface. Put some distilled water on the paper so it get soaked. Put the pre filter on it.
4) Put the upper plate with gasket properly fitted.
5) Clamp the filter assembly. Tighten the opposite clamps at a time to avoid any leakages.
6) Fix latex tubing.
7) Perform bubble point test at 40 pound pressure. If it passes the bubble point then sterilize it. If it fails then mount the filter paper again. Filter assembly should not be fully airtight while sterilizing.

Sterilization of filter assembly is done at 117 0 C for 30 minutes. After sterilization, filter the prepared batch , filtered the solution in sterilized S. S. receiving vessels. Bubble point test perform before and after the filtration.

AMPOULE WASHING :
a) Decarton the ampoules in clean plastic creates in aseptic area.
b) Transfer the creates in washing room.
c) Arrange these ampoules in S.S. trays.
d) Load tray in ampoules washing machine.
e) Put on the cycle.
f) Ampoules are washed through unit with 5 micron filtered D.M. water with alternate the flushing with filtered compressed air.
g) Unload the machine and arrange.
h) The ampoules into S.S. tray for dry heat sterilizations.

STERILIZATION :
To be sterilized at minimum 200° C for 1 hour.

STERILIZATION OF SOLUTION :

The product is aseptically filled . Sterilization is achieved by filtering through a membrane filter. Filteration is done through a 142 mm/293 mm membrane filter of 0.22 micron size. Prefilter1.5micron used is 142 mm/293 mm.

FILLING :

FILLING UNIT :

It consist, of S.S. syringes, holders, filling needles, gassing needles, silicone tubing etc.

The above should be first cleaned carefully with teepol, raw water and then washed with hot distilled water. After cleaning. Syringes deeped in distilled water and kept in S.S. tank which are then invaded into the autoclave for sterilizing. The sterilization cycle is 117 0 C for 30 minutes.

RECEIVING VESSELS :

Vessels which are used to collect the filtered solution have to be first washed with teepol solution steamed, then washed with hot distilled water and taken into the unit preparation area. Here they are rinsed twice with fresh distilled water . The opening of vessals are then sterilized at 117 ⁰ C for 30 minutes.

GARMENTS :

Garments that are used in the sterile filling area are first checked if they are torn . Torn garments are rejected. Clean garments are then folded property and two sets are put into one sterilization box open loaded into the autoclave for sterilization . The sterilization cycle is 117 ^o C for 30 minutes . After sterilization the perforation are closed . The garments are taken to the air lock and are hanged on to hangers.

GLOVES :

New gloves are washed thoroughly with DM water and then with distilled water. The gloves are also checked for any tearing and if found any, rejected . These gloves are then put into s.s. unit boxes with the perforation open and sterilized at 117⁰ C for 30 minutes.

FILING OPERATION :

Filling of ampoules with sterile solution is done in sterile area. Ampoules filling is done on four head ampoule filling and sealing machine.

Filling capacity of the machine is 80 ampoules per minute . During filling, the production supervisor has to conduct creation in process control test at regular interval.

write filing is going on movement should be restrained and there should be less talking. The machine should be kept clean.

During lunch break the full area should be cleaned , spraying of antiseptic solution should be taken up at regular intervals.

STERILIZATION :

Sterilization by filtration.

VISUAL INSPECTION :

Ampoules are taken for visual inspection. Visual inspection is done on inspection table. The inspection

is fitted with a source of illumination such as tube light.The screen has half the area paintedwith white

and half the area painted in black. The front of the light is covered so that the direct light does not

fall on the a separate table. The ampoules are checked by swirling its contacts by wrist movement

and observe for any particle or foreign matters . There should be a gap of 5 to 10 minutes after

one our of working. Trained operators should only be allowed.

Type of rejection:

Black particles
White particles
Fibres
Glass particles
Shining matters
Sealing rejection
Less / high volume
Breakage

Product Name : Dopamine Hydrochloride injection 5 ml ampoule

Self life : 2.0 Years

Colour : Clear, colurless solution.

Contents : 5.3 ml

pH : 2.5 to 5.0

Assay : Dopamine Hydrochloride U.S.P.

Limit 95.0 % to 105.0%

Theoretical yield at different stages :
Scheduled fill : 18867 yield permissible limit

Filling rejection 1.5 % : 283 18584 0 to 2.5%

Optical checking rejection 6% : 1132 17735 0 to 8.0 %

Total rejection : 1415

Normal yield : 17452

After optical inspection ampoules are kept on labeling machine .

PACKING DETAILS : Box of 50 x 5 ml
Outer of 10 x 50 x 5ml

INPROCESS CONTROLS :

PRINTING :
At the start of the batch the printing of the labels should be checked and signed by competent person.

LABELLING :
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.

Sr. No.	Packaging Material
01.	Label
02.	Inner Box
03.	Outer Box

Additional material if required may be drawn giving additional requisition slip duly authorized.

Material if in excess may be returned to stores after taking authorization.

CODING :

Ampoule labels are overprinted in label printing machine / by hand stamping with batch no. ,Mfg. date, Exp. Date, Retail price and any specific instruction.

PROCEDURE :

Ampoules are labeled on labeling machine after getting line clearance. The capacity of the machine

is 80 ampoules per minutes. The ampoules are checked for authentic appearance and any cross

labeled / dirty labeled ampoules are delabelled and labeled again . After labeling ampoules are

kept in cartons, inner boxes and then kept in outer boxes. Outer boxes are passed for taping with printed

BOPP tape by taping machine. After packing

is over left out labels are counted and destroyed .

FINISHED PRODUCT :

After final packing store in a segregated storage area .Finished products which are “ UNDER TEST ’’ must

be quarantined and segregated by fixed printed labels.

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